Associate Director, Biostatistics

Responsibilities

• Apply rigorous statistical expertise to study design, statistical analysis plans, and interpretation of results
• Provide strategic statistical input into clinical development plans and study-level decision-making
• Plan, deliver, and communicate statistical analyses and scientific reports for clinical trials
• Own the timeliness and quality of study- and submission-level statistical deliverables
• Manage vendors and monitor performance for outsourced studies
• Ensure compliance with regulatory requirements such as FDA regulations
• Contribute to interactions with regulatory authorities including FDA and EMA
• Collaborate with clinical development, data management, and statistical programming teams
• Develop and lead initiatives in process improvement and training
• Support ad hoc analyses and validate programs for data analysis and visualization

Requirements

• PhD or Master’s in Biostatistics, Statistics, or a related field
• 6 years of biostatistics experience with a PhD, or 8 years with a Master’s
• Experience supporting clinical trials in pharmaceutical, biotech, or CRO industries
• Proficiency in statistical programming languages such as SAS or R
• Knowledge of CDISC data standards (SDTM and ADaM)
• Knowledge of ICH and FDA/EMA guidelines, including ICH E9(R1)
• Strong verbal and written communication skills

Preferred Qualifications

• 2 years of leadership or people-management experience
• Prior oncology clinical trial experience with familiarity with RECIST 1.1
• Experience supporting regulatory submissions (NDA, BLA)
• Experience managing CROs and external statistical vendors
• Experience using simulation to support trial design

About the Company

Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies, including antibody-drug conjugates.